Meshing Drug and Device Manufacturers in Risk Management

By Maria Fontanazza
June 17, 2015


• Categories: 05-Quality/Regulatory, Combination Products, RC - Medical Device Audits, Certification & Verification

Last year sales of combination products hit $22 billion, according to a report released by BCC Research.* Within the next four years, the market can expect “[Regarding combination products], I think the industry is probably ahead of FDA. Because of the diversity of the agency and the different areas of responsibility, I don’t think FDA has a total view of risk management yet.”
– Ed Bills, principal consultant at ELB Consulting to enjoy a 7.1% compound annual growth rate, reaching $31 billion in 2019. In addition, there was a 7% increase in products that came into the Office of Combination Products (OCP) between 2007 and 2013. These are healthy figures from an outside perspective, but there are several underlying issues that could prevent the industry from reaching its full potential, one of which is the approach to risk management by drug and device manufacturers and how the Centers handle risk.

Both the ICH Q9 Quality Risk Management guidance document for drugs and the ISO 14971 Risk Management for Medical Devices standard define risk as the “combination of the probability of occurrence of harm and the severity of that harm”.

“Since we have two identical processes, when we try to combine the drug component and the device component into a healthcare product, we should be able to see how they fit together, but we haven’t gotten that far,” says Edwin Bills, principal consultant at ELB Consulting. “We’re not that mature yet in how we approach things.” He adds that many device manufacturers focus their risk management activities heavily on the product development phase, while pharmaceutical companies are targeting risk during the actual manufacturing of product. “We haven’t meshed the drug and device teams together to come up with this single risk management view of the final product,” says Bills.

Compounding this issue are the differing views on risk management held by CDRH, ODE, CDER, and CBER. “The manufacturer is caught in the middle. We’re trying to satisfy all these “customers” with a process that should be a single process, but each of these parts of the agencies has different ideas,” says Bills. “It’s a complex situation, and perhaps what needs to happen at some point in time is for everyone to sit down and try to come up with what is the right [singular] approach.”

Industry experts will be discussing how to find common ground at the Combination Products conference June 24-25, in Washington, DC. Register now.

* The BCC Research report references drug-device combinations only